HS-IRBs News June 2017

HS IRBs Office Closure

The HS IRBs office will be closed Tuesday, July 4th, in observance of Independence Day.

LAST CALL: Upcoming Beginners Workshop

The Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the HS IRBs processes or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. The June date and registration link can be found below; the next training will not be held for another six weeks.

Updated Five-Year Replacement Policy

The UW Human Research Protection Program (HRPP) recently approved revisions to the campus' five-year replacement/renewal policy. These revisions expand the types of studies for which a replacement application does NOT need to be submitted. New studies excepted from the policy now include:

Non-exempt medical record (NEMR) review applications

Studies that are permanently closed to enrollment even if other study activities involving subjects still ongoing

HS IRBs Staffing and Workload Update

The HS IRBs Office is currently working to fill several open staff reviewer positions. Researchers can help us during this time of short-staffing by doing the following:

If you have a new study that requires approval by a particular deadline, please inform us of this when you submit the application. Use the “Comment” box when submitting the application to provide detailed information about the deadline. Our office will use these details to triage and prioritize studies to the best of our ability.

If you have a new study currently under review for which a specific deadline for approval has emerged (e.g., notification of potential funding), please contact the staff reviewer assigned to your application to notify them of the new deadline. Again, we will do our best to prioritize applications with such deadlines.

Finally, if you are or plan to participate in a multisite study for which another institution is serving as the lead site or coordinating center, please contact the HS IRBs Reliance Team (irbreliance@wisc.edu) to discuss the possibility of ceding IRB review to a non-UW IRB.

New Effective Date for NIH Single IRB Review Policy

NIH has recently announced that the effective date for its single IRB review policy has been pushed back from September 2017 to January 25, 2018. The policy requiring use of a single IRB for multisite studies will now apply to all competing grant applications for due dates on or after January 25, 2018. If you have questions about single IRB review, please contact the HS IRBs Reliance Team (irbreliance@wisc.edu).

Coming Soon: ARROW Edition of the Newsletter

ARROW is undergoing a number of changes this year to improve the user experience for the research community and others. To help keep our researchers up to date on forthcoming changes and invite your feedback, we will soon be sending out ARROW-specific editions of the newsletter in addition to our regular monthly edition. Stay tuned!

Feasibility Assessment Pilot

The Institute of Clinical & Translational Research (ICTR) will pilot an initiative to improve feasibility assessment of non-exempt human subjects research, partnering with the Department of Surgery. Feasibility assessments should assist research teams by: 1) identifying and addressing potential factors that can prevent or slow study execution and completion; and 2) connecting them to resources for the successful implementation and conduct of their investigative pursuits.

Feasibility assessments include evaluation of subject recruitment plans, study team qualifications, and financial support for the research. As such, these assessments are best accomplished at the department level, given their explicit knowledge of personnel, resources, and patient populations, among other factors.

The Health Sciences IRBs Office and ICTR Scientific Review Committees (SRCs) will assist in monitoring the implementation of this forthcoming requirement ONLY for researchers in the Department of Surgery. As of July 1st, the ICTR SRCs and Health Sciences IRBs will verify that departmental feasibility has been completed prior to SRC or IRB review proceeding. This includes projects that may be reviewed by an IRB external to the University of Wisconsin-Madison, such as Western IRB, the NCI CIRB, and IRBs at other academic institutions. If this pilot is found to be successful, ICTR intends to expand this initiative to other clinical research.

Department of Surgery researchers with questions about how to obtain a feasibility assessment can email Lisa Werning at werning@surgery.wisc.edu.